MAUDE Adverse Event Report: PERFUSION SYSTEMS MEDTRONIC TUBING PACK; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number BB8D56R9

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use of the custom tubing pack, it was noted that the tubing ruptured near the end of the procedure.The pack was used to complete the procedure.There was no adverse affects to the patient.The patient lost approximately 30cc's of blood.

Manufacturer Narrative

Conclusion; the customer said that the rupture occurred at the end of the procedure and he noticed an occlusion before the rupture.Without the product we cannot perform thickness check or durometer confirmation.It appears to be damage from the roller pump.These reports are rare and usually attributed to over-occlusion or the tubing placed improperly in the raceway.Correction: mfg name corrected.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MEDTRONIC TUBING PACK
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8334459
• MDR Text Key: 136616662
• Report Number: 9612164-2019-00486
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00643169652941
• UDI-Public: 00643169652941
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K924529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2020
• Device Model Number: BB8D56R9
• Device Catalogue Number: BB8D56R9
• Device Lot Number: 216733849
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2019
• Initial Date FDA Received: 02/13/2019
• Supplement Dates Manufacturer Received: 03/20/2019
• Supplement Dates FDA Received: 03/25/2019
• Date Device Manufactured: 12/06/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1